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The McLean-Ring Nasojejunal Feeding Tube Set is intended for enteral feeding and medication in adult and pediatric populations. The device is intended to be used in the treatment of the following pediatric subgroups: children and adolescents.

The McLean-Ring Nasojejunal Feeding Tube Set is composed of a feeding tube and wire guide. The feeding tube is made of a 9.5 French polyurethane tube. The feeding tube is available in 130 centimeters only, measured from the distal tip to the proximal hub. The distal end of the feeding tube features six sideports. The distal tip of the feeding tube is open with a smooth round finish. A 0.650-inch long stainless steel weight is fit outside the distal end of the feeding tube and is completely covered with a shrink tube, forming 0.180-inch outer diameter over the weight. The proximal end of the feeding tube features a hub with a cap that is made of polyurethane. The wire guide is made of stainless steel in a 0.038-inch diameter. The wire guide is 275 centimeters long. In addition, the entire length of the wire guide is coated with PTFE. The distal end of the wire guide is straight but flexible. The subject device, McLean-Ring Nasojejunal Feeding Tube Set, may be introduced directly when there is adequate peristalsis and no gastric outlet obstruction. Alternatively, the feeding tube may be passed over a wire guide. The feeding tube is intended to be indwelling up to 30 days and is for one-time use.

The provided document is a 510(k) Premarket Notification from Cook Incorporated for the McLean-Ring Nasojejunal Feeding Tube Set. It describes the device, its intended use, and its comparison to a predicate device (Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube).

Critically, this document describes a medical device, specifically a feeding tube, not an AI/ML-based medical device. Therefore, the concepts of "acceptance criteria for an AI/ML device," "study proving the device meets acceptance criteria for an AI/ML device," "sample size used for the test set," "data provenance," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "training set," and "how ground truth for training set was established" are not applicable to the information provided.

The document focuses on the substantial equivalence of a physical medical device. The "studies" mentioned are bench testing to assure reliable design and performance (e.g., dimensional, flow rate, kink resistance, MRI compatibility) and biocompatibility testing. Additionally, clinical evidence is provided through a review of published literature on the use of similar feeding tubes in pediatric patients. This literature review is used to support the safety and performance for the device's intended use in children and adolescents, not to prove the performance of an AI algorithm.

Since the request is about an AI/ML device and the provided text describes a physical medical device, I cannot extract the requested information.

If you have a document describing an AI/ML medical device, please provide it, and I will be able to answer your questions accordingly.

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The Lunderquist Fixed Core Wire Guides are intended to facilitate placement of devices used during diagnostic and interventional procedures.

The Lunderquist® Fixed Core Wire Guide, subject of this submission, is a Class II device according to 21 CFR §870.1330; product code DQX (Wire, Guide, Catheter). The subject device consists of a mandril design with a distal spring coil anchored over the distal portion of the mandril and a cannula anchored over the proximal portion of the mandril. The Lunderquist Fixed Core Wire Guide is available with an outside diameter of 0.038 inch and a length of 120 centimeters (cm). The tip portion of the subject device is straight. The Lunderquist® Fixed Core Wire Guide is a packaged, sterile device intended for single patient use.

The document provided describes the K181353 submission for the Lunderquist® Fixed Core Wire Guide. It is a Class II medical device, product code DQX (Wire, Guide, Catheter), intended to facilitate the placement of devices during diagnostic and interventional procedures. The submission outlines various performance tests conducted to demonstrate that the device met applicable design and performance requirements and supports substantial equivalence to its predicate device, the Mandril Wire Guides (K171997).

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that for each of the performance tests, "The predetermined acceptance criteria were met." However, the specific quantitative acceptance criteria or the reported device performance values are not provided in the text. The document only confirms qualitative success in meeting these criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for any of the performance tests. It also does not mention data provenance in terms of country of origin or whether the studies were retrospective or prospective. These were laboratory-based performance tests, not clinical studies with patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided in the document, as the studies described are laboratory-based device performance tests against pre-defined engineering and safety standards, not studies involving expert interpretation of medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document, as the studies described are laboratory-based device performance tests against pre-defined engineering and safety standards, not studies involving human judgment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document describes laboratory performance tests of the device itself, not studies comparing human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This concept is not applicable to the device described. The Lunderquist® Fixed Core Wire Guide is a physical medical instrument, not a software algorithm. Therefore, "standalone" algorithm performance is not a relevant metric. The tests performed are analogous to "standalone" performance of the physical device.

7. The Type of Ground Truth Used

The ground truth for these performance tests was based on established ISO and ASTM standards, as well as FDA guidance documents (e.g., ISO 10993-1:2009, ISO 11070:2014, ASTM F640-12, FDA Coronary and Cerebrovascular Guidance (1995)). This represents a "standard-based" ground truth, where the device's physical and mechanical properties are measured against predefined acceptable ranges or thresholds.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The Lunderquist® Fixed Core Wire Guide is a physical medical device, not an AI/ML algorithm that requires a training set. The tests described are for verification and validation of the device's physical properties.

9. How the Ground Truth for the Training Set was Established

This information is not applicable and not provided, as the device is not an AI/ML algorithm requiring a training set with established ground truth.

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